On March 19, the FDA's Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly discuss the supplemental New Drug Application (sNDA) for the expanded use of Breo Ellipta (fluticasone furoate and vilantrol dry powder for inhalation) for the once-daily treatment of asthma in patients at least 12 years old.

Breo Ellipta is currently approved for the once-daily treatment of the symptoms of chronic obstructive pulmonary disease (COPD). It is being jointly developed by GlaxoSmithKline (GSK+0.7%) and Theravance (THRX+0.2%).

The product is a fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action. Aclidium bromide is an anticholinergic or long-acting muscarinic antagonist that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both are currently approved as stand-alone therapies for the maintenance treatment of COPD in the U.S. and Europe.

Genuair is a multi-dose pre-loaded dry powder inhaler that utilizes optical and acoustic signals to inform the patient that the correct dose has been delivered.

GlaxoSmithKline (NYSE:GSK) has finished recruiting 2,800 people with Chronic Obstructive Pulmonary Disease (COPD) living in Salford, England to participate in a one-year Phase 3 open-label study to explore the effectiveness of Relvar Ellipta (fluticasone furoate "FF"/vilanterol "VI" 100/25 mcg) compared to other COPD treatments when used in a broad group of people living and managing their COPD on a daily basis.

The Salford Lung Study is the first "real-world" study of its kind in the world for a medicine prior to approval, conducted in one geographic location and run by GSK in collaboration with local healthcare providers.

Traditionally, drugs are evaluated in carefully-controlled randomized controlled trials on specific patient populations. Frequently, these trials exclude patients with additional conditions, or co-morbidities, that could influence the outcome. There is a need for additional information to complement the results from randomized trials in order to better understand a drug's potential when used in under real world circumstances. The Salford Lung Study is designed to provide this information.

The primary endpoint of the Salford trial is the mean annual rate of moderate and severe exacerbations. The study should finish in late 2015 with the first results expected in 2016.

The three highest doses of dupilumab in combination with standard-of-care therapy met the primary endpoint of a statistically significant improvement from baseline in forced expiratory volume over one second (FEV1) at week 12 in patients with high blood eosinophils (>= 300 cells/microliter) compared to placebo in combination with standard-of-care therapy. Also, two doses of dupilumab (200 mg every other week and 300 mg every other week) showed a statistically significant improvement in mean percent change in FEV1 and a reduction in severe exacerbations, both in the high eosinophils group and the overall study population.

Dupilumab blocks IL-4 and IL-13, two cytokines required by the Th2 immune response. Some researchers believed that targeting the Th2 pathway would limit the benefit in asthmatics with high eosinophils, but this study demonstrated that it could be effective. Final results from the trial will be presented at a future medical conference.

The FDA accepts Boehringer Ingelheim's NDA for Spiriva Respimat (tiotropium bromide) for the maintenance treatment of asthma in patients at least 12 years old who remain symptomatic on at least inhaled corticosteroids.

Spiriva is currently cleared for the maintenance treatment of bronchospasm (HandiHaler) associated with chronic obstructive pulmonary disease (COPD) and to reduce COPD exacerbations.

The Respimat inhaler provides a pre-measured amount of medicine in a slow moving mist that helps the patient inhale the drug. It is designed to deliver the medication in a way that does not depend on how fast air is breathed in from the inhaler.